Effects of Genomic Profiles on Thromboembolic Risk in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Multicenter, prospective observational study (15 Oncologic Centers, in Italy). The purpose of the study is to assess the thromboembolic potential in patients with oncogene-addicted and wild-type NSCLC. The primary aim of this project is to evaluate the association between oncogene mutations and levels of plasma parameters of the activated coagulation cascade as the plasma levels of TF, thrombin generation, IL 6, vWF, ADAMTS-13 activity, PAI-1, and soluble P-selectin in NSCLC patients. A total of 500 NSCLC patients with a diagnosis (cytologically or histologically confirmed) of locally advanced or metastatic disease will be enrolled in the study, with a ratio of 1:1 for oncogene addicted or wild-type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (i.e., patients expressing EGFR mutations, KRAS mutation, ALK or ROS1 rearrangements); the wild type group (Group B): patients without oncogene mutations, categorized in 2 subgroups according to expression of PD1/PD-L1 mutation or not. Patients will be followed up prospectively for 6 months or until death, VTE event, loss to follow-up, or voluntary consent withdrawal. This study will evaluate the effects of EGFR, KRAS mutations and ALK/ROS 1 and PD-1/PD-L1 rearrangements on the expression of TF and thrombin generation or the interaction between inflammation and endothelial or platelet and cancer cells, in patients with NSCLC. The study will also evaluate the potential correlation between VTE events and the expression of oncogene mutations in patients with NSCLC. The results of this study could generate the hypothesis of including the genetic profile as variable for a risk-stratification tools and decision-making algorithms in NSCLC patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• • Patients aged 18 years or older,

‣ Cytological or histological confirmation of NSCLC,

⁃ Locally advanced or metastatic disease (Stage III-IV),

⁃ Patients starting a new anticancer treatment for locally advanced/metastatic disease (first or further line of treatment),

⁃ Testing for oncogenic (EGFR, KRAS, ALK, ROS1 and PD-1/PD-L1) profile performed,

⁃ Written informed consent

Locations
Other Locations
Italy
Emily Oliovecchio
RECRUITING
Perugia
Contact Information
Primary
Melina Verso, Professor
melina.verso@unipg.it
0039+0755782326
Backup
Emily Oliovecchio, doctor
emily.oliovecchio@gmail.com
Time Frame
Start Date: 2024-02-09
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 500
Treatments
patients with diagnosis of locally advanced or metastatic NSCLC
NSCLC patients will be enrolled in the study with a ratio 1:1 for oncogene addicted or wild type group. The oncogene-addicted group (Group A): patients with at least one oncogene mutation (ie. patients expressing EGFR mutations, KRAS mutation, ALK or ROS1 rearrangements); the wild type group (Group B): patients without oncogene mutations, categorized in 2 subgroups according to expression of PD1/PD-L1 mutation or not.
Sponsors
Leads: University Of Perugia

This content was sourced from clinicaltrials.gov

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